Sterile Compounding. Jessica Tagerman, PharmD, Rph

Transcription

1 Sterile Compounding Jessica Tagerman, PharmD, Rph

2 What is Sterility?

3 Sterility & Sterile Compounding Sterile = free from bacteria or other living microorganisms; totally clean Sterile compounding is the preparation of custom medications to prevent contamination and maintain patient safety

4 What types of formulations require sterile compounding?

5 Think of: Baxter Products! Dianeal! Extraneal

6 Parenteral Bags Minibag, Prefilled Syringes, Vial, Ampule Minibag Piggybacked onto LVP

7 Types of Compounding Products Parenteral Products: Products that bypass the enteral system Large volume parenteral (LVP) Volume greater than 100 ml Generally the fluid is the treatment Small volume parenteral (SVP) Volume less than 100 ml Medication is the treatment Can be piggy backed onto LVP s Includes minibags

8 In order to really understand the process of sterile compounding, we are going to compare it to

9 A VIP Club!

10 The VIP Club Every club has rules and expectations. What resources can you use to find out more information before you go?

11 Researching the VIP club.. Word of mouth Facebook.. Yelp.. The VIP Club website..

12 Sterile Compounding Sterile compounding also has rules, regulations, and expectations. Where can you go to find this information?

13 USP 797 USP 795 = non-sterile compounding procedures and guidelines Hint! USP 797 = sterile compounding procedures and guideline First 1000 chapters are We enforceable learned non-sterile by agencies such as the FDA and TJC compounding before sterile compounding. 795 comes before 797!

14 The VIP Club Every club worker has a specific job function. Without proper training of these employees, patrons of the club may become unsatisfied, rowdy, or dangerous.

15 Sterile Compounding Personnel training is also VERY important in sterile compounding!

16 Sterile Compounding Personnel Training Without proper technique and cooperation from the compounding technician, a product will not actually be sterile. Training must be documented before an individual starts sterile compounding Didactic training, written assessments, skills assessment, and media-fill test are all required to prove competency

17 The VIP Club What do you do at the VIP club?

18 Sterile Compounding What do you do in order to compound a sterile product? (In other words, what techniques are used in sterile compounding?)

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20 Vials Ampules Working With Vials & Ampules

21 Working with Vials Two types of vials containing active drug containing solution containing lyophilized powder 21

22 Withdrawing solution from a vial (no reconstitution necessary) Introduce into the vial a volume of air equal to the volume of solution to be removed draw solution into a syringe; remove air bubbles plunger and tip of the syringe are sterile and must not be touched

23 Preparing Reconstituted Medications Reconstitution: Mixing a liquid and powder to form a suspension or solution Solvent: Liquid; what is used to dissolve the powder (diluent) Solute: Powder being dissolved Solution: Liquid + Powder Add solvent in small portions to solute Check for signs of incompatibility (precipitate, change in color) Add a BUD date/time + Shake well auxiliary label

24 Preventing Coring Preventing Coring Coring: When a needle damages the rubber closure of a parenteral container causing fragments of the closure to fall into the container and contaminate its contents Place vial on flat surface. Position needle point on closure surface at ~ 45 angle. Press down on needle while gradually bringing it to an upright position (90 angle) Perspective Press/Morton Publishing Company 24

25 Opening an Ampule 2016 Perspective Press/Morton Publishing Company Gently tap top of ampule to bring medication to lower portion of ampule. Clean neck with alcohol swab; grasp ampule between thumb and index finger at the neck while keeping swab in place. Forcefully snap neck away from you. 25

26 Ampules, Transferring Solution Tilt ampule down ~ Perspective Press/Morton Publishing Company Attach filter needle to a syringe and insert into ampule. Withdraw solution keeping needle submerged to avoid drawing air. Withdraw needle and remove all air bubbles. Exchange filter needle and transfer solution to final container. 26

27 Syringes & Needles Basic Parts of a Syringe Measuring Volume Syringe Sizes 1 ml to 60 ml Perspective Press/Morton Publishing Company

28 Syringes & Needles, cont d Basic Parts Of A Needle Needle Lengths 3/8 to Perspective Press/Morton Publishing Company Needle Gauges The LOWER the gauge, the THICKER the needle 28

29 Needle Free Devices Vial Adapters Perspective Press/Morton Publishing Company

30 Needle Recapping Should not be done unless absolutely necessary Use the one-handed scoop method Should NEVER be done for vaccines why?

31 The VIP Club VIP Clubs have very specific floor plans to ensure exclusivity and customer satisfaction

32 Step 1 Step 2 Step 3 Step 4

33 Compounding pharmacies also have very specific floorplans/building requirements to ensure sterility..

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35 You can t have a good time at a club without certain things.

36 Just like you can t perform sterile compounding without certain things.

37 Primary Engineering Controls for Sterile Compounding

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39 Primary Engineering Controls A device that provides appropriate air quality for compounding sterile preparations Biological safety cabinets (bscs) Laminar airflow workstations (LAFW)

40 Types of Laminar Flow Hoods Horizontal: Air is pushed towards the personnel completing the compound Vertical: Air is pushed to the bottom of the hood Used for hazardous substance compounding (chemo)

41 Standard Operating Procedures, Laminar Flow Hood Supplies in the hood are disinfected with 70% isopropyl alcohol No objects should be between the first air from a HEPA filter and the critical site Procedures are performed to reduce touch contamination; gloves are disinfected with 70% isopropyl alcohol All rubber stoppers of vials, bottles, and ampule necks should be wiped with 70% isopropyl alcohol for at least 10 seconds before preparing CSP 41

42 Cleaning Frequency Hood: beginning of each shift, before each batch, no more than 30 minutes after last cleaning while compounding, after spills, when contamination is known or suspected Counters and work surfaces: daily Floors: daily Walls, ceilings, and storage shelving: monthly

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44 What s wrong with this picture?

45 Biological Safety Cabinets (BSCs) Enclosed, laboratory workspace Protect personnel and the environment 3 classes a Class II, Type A1 cabinet is the minimum recommended environment for preparing chemotherapy agents A Class II, Type A1 Biological Safety Cabinet

46 Types of Biological Safety Cabinets A hoods: Recirculate a portion of the air (after 1 st pass through HEPA filter) within the hood and exhaust a portion of the air back into the buffer room B1 hoods: Expel most of the contaminated air through a duct to the outside atmosphere and passes through a HEPA filter B2 hoods: Remove all contaminated air to the outside atmosphere after passing through HEPA filter. Air is not recirculated OR returned to the buffer room B3 hoods: Use recycled air within the hood. All exhaust air discharged to outside atmosphere. Type A hoods can be converted to type B3.

47 The VIP Club Let s go back to the rules and regulations of the VIP club. Here is what you read during your initial research of the club: No fighting, no inappropriate behaviors, total intoxication will not be tolerated, if you need to get sick, only do it in the bathroom.

48 What are the rules, regulations, and standard operating procedures of a sterile compounding pharmacy?

49 Standard Operating Procedures Access restricted to qualified personnel Cartoned supplies decontaminated using spray disinfectant Not frequently used supplies stored in anteroom Carts used to bring in supplies not rolled past anteroom Supplies disinfected before being brought into buffer room Nonessential supplies that shed particles not taken into buffer room Traffic in and out is minimized No outer garments/accessories to be worn Hands and forearms washed with soap and water for at least 30 seconds Must wash hands before putting on gloves No food, drink or gum

50 Procedures for Preparing IV Compounds Flow hood should be turned on at least 30 minutes prior to starting Wear Personal Protective Equipment (PPE) Clean the hood, pole to hang IV bags, and sides of hood by moving from top to bottom and back to front (down, then forward) Collect supplies Check for expiration dates and leaks Remove dust coverings first Pre-sterilized needles, syringes, and filters Position supplies in hood Critical areas should always be exposed to air flow

51 Responsibility of Personnel Opened or partially used products must be stored under restricted access Devices and equipment are clean, accurate and effective Packaging is appropriate for maintaining sterility and strength until BUD Labels on CSPs list names and amounts/concentrations of active ingredients Before dispensing, the clearness of a solution is visually confirmed BUD s assigned based on testing and obtaining information from reliable sources (Trissels)

52 The VIP Club What do you wear?

53 Sterile Compounding What do you wear when you re performing sterile compounding?

54 Garbing- Step 1

55 Hand Washing- Step 2

56 Gloving - Step 3

57 Hand

58 Additional Sterile Compounding

59 Types of Injectable Water Purified water USP: not intended for parenteral administration. Used to reconstitute oral products Water for injection USP: Not sterile, cannot be used in aseptic compounding of sterile products Sterile water for injection USP (SWFI): sterilized, but has no antimicrobial agents. Can be used in parenteral solutions. Bacteriostatic water for injection USP: Sterile water with antimicrobials, can be used for injection Sterile water for irrigation USP: sterilized but has no antimicrobial agents, used as an irrigating solution

60 Types of Solution Normal Saline (NS) 0.9% NaCl (isotonic) ½ Normal Saline (1/2 NS) 0.45% NaCl (hypotonic) ¼ Normal Saline (1/4 NS) 0.225% NaCl (hypotonic) 5% Dextrose in water (D5W) 5 grams dextrose per 100 ml 10% Dextrose in water (D10W) 10 grams dextrose per 100 ml 5% Dextrose in normal saline (D5NS) Lactated Ringer Solution (LR) Sterile Water (SW) y.html?cid=20016&lid=10001&hid=20001&cate goryid=38453

61 Preparing Antineoplastics (Chemo) Must be done in a vertical flow hood Must wear special clothing Surface should be covered in plastic-baked absorbent paper which is then disposed of in hazardous waste Double gloves Closed front surgical gowns Sterile alcohol pledget wrapped around needle and vial top during withdrawal Cautionary labels affixed to medication bags

62 Preparing Total Parenteral Nutrition (TPN) Normally contains 50% dextrose, 10% amino acids, and 20% fat Aseptic technique is REQUIRED, it is infused into the right atrium of the heart Automatic TPN compounders can be used May be premixed from the manufacturer, however electrolytes, vitamins, and medications must be added to the bag as needed

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64 Preparing Radiopharmaceuticals May be diagnostic or therapeutic May be oral, IV, or inhaled Quality control tests are performed to ensure it is sterile, pyrogen free, and pure Proper handling of isotopes during preparation must be ensured Must be prepared in vertical flow hood Strict packaging requirements, including being shipped in specific containers Safety principles of time, distance, and shielding are observed Special training must be completed (nuclear pharmacy)

65 Special Solutions Total parenteral nutrition (TPN) solutions hypertonic admixtures of dextrose, fat, protein, electrolytes, vitamins, and trace elements TPN preparation systems TPN administration Dialysis Solutions Peritoneal dialysis solutions Irrigation Solutions Surgical, urological glycine, and sorbitol Perspective Press/Morton Publishing Company

66 Handling and disposal requirements

67 Types of Waste Solid: Any solid, liquid, or gas waste Hazardous: Any substance capable of adverse effects on the health and safety or the environment of a human being Regulated by OSHA All employees must be aware of risks and precautions Must keep SDS s for all materials Infectious: includes blood, blood products, bodily fluids, sharps, laboratory waste

68 Waste Characteristics Ignitability: Flash point less than 60 C Potassium Permanganate Silver Nitrate Collodion Corrosivity: ph less than 2 or greater than 12.5 Glacial acetic acid Sodium hydroxide Reactivity: Liable to explode, react violently, or release toxic gases when in contact with water Nitroglycerin Toxicity: Contains a regulated substances at a concentration above the limit Zinc Selenium

69 Hazardous Drugs (Hormones, Chemo) Wear doubled gloves Inner glove beneath the cuff, outer glove above it Never touch gloves with skin Changed hourly or after every contamination Use leur-lok syringes Special chemo sharps container Must be put into hazardous waste bins Must be prepared in a vertical flow hood (BSC)

70 Radioactive Waste Regulated by Dept. of Transportation (DOT) Container must have a warning label A placard must be placed on the vehicle if it carries Yellow III material Materials must be braced inside vehicle

71 USP 797 Terminology Ante-room: All preparations for IV compounding are gathered in this area (labels, gowning, and drug materials) BUD: Beyond use date Buffer area: An area where hoods are kept and sterile compounding takes place Clean area: a space where microbial containment is kept at specific levels to ensure cleanliness Compounded Sterile Product (CSP): a sterile drug product prepared by compounding prior to administration Critical site: An area exposed to air or touch, such as a vial, needle, or ampule Direct compounding area (DCA): a critical area within an ISO class 5

72 Terminology Continued Media-fill test: A test performed on compounded products to ensure no contamination has occurred during prep Negative-pressure room: a room in which air flows into the room and away from adjacent rooms, which results in positive pressure in the room Positive-pressure room: A room in which air flows out of or toward adjacent rooms, which results in a lower pressure in the room ISO (international standards organization) Class 5: no more than 100 particles 0.5 microns or larger per cubic foot of air (most sterile) ISO Class 7: no more than 10,000 particles 0.5 microns or larger per cubic foot of air ISO Class 9: no more than 100,000 particles 0.5 microns or larger per cubic foot of air

73 What happens if a product that is supposed to be sterile isn t?

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75 Questions?!